Teva Recalls Mimvey Lo Tablets Due to Impurity Test Failures
Teva Pharmaceuticals USA is recalling specific lots of Mimvey Lo tablets because they failed impurity specifications for norethindrone.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or fatalities, fitting the criteria for a moderate severity score.
Plain-English summary
Teva Pharmaceuticals USA is recalling 17,473 cartons of Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg. The affected product is packaged in 3 blister cards per carton and is available by prescription only. The recall involves Lot # 33809881A (Exp 05/17) and Lot # 33811151A (Exp 08/17).
The recall was initiated because the product failed impurities/degradation specifications, specifically regarding out-of-specification test results for the norethindrone impurity. The product was distributed nationwide in the United States.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatments. The product was manufactured by Barr Laboratories, Inc., and manufactured for Teva Pharmaceuticals USA.
The recalled product
- Product
- Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-18), packaged in 3 blister cards per carton (NDC 0093-5454-62), Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva…
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 17,473
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot # 33809881A
- Exp 05/17
- 33811151A
- Exp 08/17
Distribution
Distributed nationwide across the United States.
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